SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA premarket approval P150003/S017 · decided 2016-08-18
Approval details
- PMA number
- P150003
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-07-25
- Decision date
- 2016-08-18
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Update to the software used on the Automated Catheter Manufacturing Line Distal and Port Load and Unload stations in Galway.
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